# PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion

> **NCT05343715** · PHASE1 · COMPLETED · sponsor: **Bio Sidus SA** · enrollment: 24 (actual)

## Conditions studied

- Fabry Disease

## Interventions

- **BIOLOGICAL:** Agalsidase beta from Biosidus 1 mg/kg
- **BIOLOGICAL:** Fabrazyme (agalsidase beta) 1 mg/kg

## Key facts

- **NCT ID:** NCT05343715
- **Lead sponsor:** Bio Sidus SA
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-10-23
- **Primary completion:** 2022-03-06
- **Final completion:** 2022-04-17
- **Target enrollment:** 24 (ACTUAL)
- **Last updated:** 2025-10-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05343715

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05343715, "PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT05343715. Licensed CC0.

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